# Development of a novel OTC naloxone product to be affordably priced and widely accessible

> **NIH NIH UF1** · POCKET NALOXONE CORP. · 2021 · $2,381,970

## Abstract

Title: Development of an Affordable, Novel OTC Naloxone Product to Reverse Opioid Overdoses
Program Summary (Abstract)
Every day, 180 Americans die from opioid overdoses. Starting with the misuse of prescription opioids,
then increased use of heroin, and now with the emergence of synthetic and powerful opioids such as
fentanyl, the number of overdose deaths will continue to remain high. Naloxone, first approved by the
FDA nearly 50 years ago, is a safe and effective opioid antagonist used to treat and reverse opioid
overdoses. The auto-injector product EVZIO was approved in 2014 (now discontinued) was priced at
$2,000 retail for one dose. The intranasal spray product, Narcan Nasal Spray was approved in 2015
and is priced at $140 retail for two doses. Generic intranasal sprays are currently blocked from entering
the market due to patent litigation by the owners of Narcan. Additionally, even though many states do
not require a prescription for purchase, these products continue to be kept behind-the-pharmacy
counter. Apart from the price, stigma and its associated embarrassment and fear prevents speaking to
a pharmacist to purchase a naloxone product. Therefore, the FDA has made an unprecedented call for
an over-the-counter (OTC) naloxone products in January 2019 and tested and published a consumer-
friendly model drug facts label (DFL) to support urgent development of such products. There are
currently no OTC naloxone products approved by the FDA. To address this unmet need, Pocket
Naloxone Corp. (PNC) has developed a novel intranasal delivery method for naloxone intended to be
affordable and used in OTC settings ($10 per dose). There are precedent clinical pathways for new
naloxone products that have been approved by the FDA (although only available with a prescription)
including appropriate approaches on study designs to evaluate bioequivalence for PNC’s intranasal
naloxone compared to reference naloxone product. A first-in-human pilot clinical study has been
completed and the second part of the pilot program will refine dosing and administration. This is
expected to begin in second half of 2021 followed by a final pivotal comparative bioequivalence study.
The specific aims of this U01 grant are to: (1) Utilize data obtained from pilot first-in-human
pharmacokinetic study and initiate new pilot studies to refine administration method and target doses
and conduct final pivotal comparative bioequivalence study to naloxone nasal spray; (2) Establish user
Instruction for Use for the target general public (lay persons) and consumer drug-fact label through (a)
FDA required Human Factors study testing and (b) FDA established label comprehension study; (3)
Submit an NDA to the FDA and apply for Priority Review status for the OTC naloxone nasal swab.

## Key facts

- **NIH application ID:** 10400589
- **Project number:** 1UF1DA053806-01A1
- **Recipient organization:** POCKET NALOXONE CORP.
- **Principal Investigator:** Ashanthi Mathai
- **Activity code:** UF1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,381,970
- **Award type:** 1
- **Project period:** 2021-09-30 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10400589

## Citation

> US National Institutes of Health, RePORTER application 10400589, Development of a novel OTC naloxone product to be affordably priced and widely accessible (1UF1DA053806-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10400589. Licensed CC0.

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